When you choose idv, you choose a first-class team of specialists made up of bimetricians, medical practitioners, mathematiciens, and computer scientists. Our team will use their competance and extensive experience to carefully work through your list of deficiencies.
idv has 40 years of practical experience performing clinical studues: We have planned, monitored, and evaluated more than 800 national and international studies. For many years we have been deeply involved in consulting activities with a comprehensive spectrum of services (FDA, BfArM, BMGF, judicial).
Deficiencies
Lists of Deficiencies from Regulatory Authorities - Do you also have trouble with these?
The Spectrum of our Services for your Problems:
- Detailed investigation of lists of deficiencies and the compilation of biometrical expert opinions
- Re-analyses for validation of study results
- Sensitivity analyses for handling special problem areas
- Representation of your interests - as experts - before regulatory authorities and in court
Sensitivity Analyses
idv provides a wide spectrum of methods suitable for sensitivity analyses related to the processing of special problems
- Efficient parametric and non-parametric procedures in accordance with state-of-the-art biometry,
- Intelligent strategies for handling multiple tests or endpoints,
- New evaluation of equivalence and/or non-inferiority (choice of delta),
- Relevance measure with the help of appropriate effect size measures and confidence regions (ICH E9, CONSORT guideline),
- Professional multi-center evaluation and interactive investigations (ICH E9)
- Testing of predication-relevant factors (EU-PtC)
- Testing and, where applicable, redefinition of evaluation populations
- Detailed analyses of drop-out cases and developing indisputable evaluation strategies
- Appraising interfering concomitant medication and developing appropriate procedures for reducing bias